肝泰舒胶囊治疗病毒性乙型肝炎的系统评价与Meta分析
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摘要
该文评价肝泰舒治疗病毒性肝炎的疗效和安全性。通过计算机检索Cochrane Library,PubMed、万方数据库、维普、中国知网(CNKI)、中国生物医学文献数据库(Sino Med),检索时限为建库至2018年11月,纳入肝泰舒治疗病毒性肝炎的随机对照试验,采用Cochrane 5. 0推荐的偏倚风险评估工具对纳入的研究进行方法学质量评价,通过使用Rev Man 5. 3软件进行Meta分析,对于不能合并的研究采用描述性分析。利用GRADE软件对系统评价的结果进行证据分级。共纳入6项随机对照试验,Meta分析结果显示,在HBe Ag阴转率(RR=2. 09,95%CI[0. 90,4. 85],P=0. 09,I2=0%)、HBV-DNA阴转率(RR=1. 49,95%CI[0. 56,3. 95],P=0. 43,I2=0%)和治疗前后谷丙转氨酶(ALT)水平的变化(RR=-6. 28,95%CI[-72. 83,60. 27],P=0. 85,I2=99%)方面,肝泰舒胶囊与东宝甘泰片无统计学差异。在生活质量方面,肝泰舒胶囊能够明显改善乙肝患者的症状,且不良反应较少。GRADE证据等级为"低级别证据"。结果表明肝泰舒胶囊与东宝甘泰片在抗病毒方面无统计学差异,而相较于当飞利肝宁胶囊在抗病毒方面优势明显,能够明显改善慢性乙型肝炎患者的症状,临床安全性较好,可以考虑在辨证施治的情况下应用。鉴于纳入研究的质量偏低,需要更多高质量的临床试验进行证实。
To evaluate the efficacy and safety of Gantaishu Capsules in the treatment of viral B hepatitis. The randomized controlled trials( RCT) retrieved from Cochrane Library,PubMed,Sino Med,CNKI,Wan Fang and VIP were enrolled. The methodology quality of the included studies was evaluated,and a Meta-analysis was performed using Rev Man 5. 3 software. A total of six randomized controlled trials were included. Meta-analysis results showed that the similarities in the negative conversion rate of HBe Ag( RR = 2. 09,95%CI[0. 90,4. 85],P = 0. 09,I2= 0%),the HBV-DNA negative rate( RR = 1. 49,95% CI[0. 56,3. 95],P = 0. 43,I2= 0%) and the changes in ALT levels before and after treatment( RR =-6. 28,95%CI[-72. 83,60. 27],P = 0. 85,I2= 99%),with no statistical difference. In terms of quality of life,Gantaishu Capsules can significantly alleviate the symptoms of hepatitis B patients,with less adverse reactions. Gantaishu Capsules and Dongbao Gantai Tablets were similar in antiviral effect. In this term,Gantaishu Capsules was superior to Dangfei Liganning Capsules. It can significantly alleviate the symptoms of chronic hepatitis B patients,with a good clinical safety.Therefore,it can be applied in the case of syndrome differentiation and treatment. In view of the low quality of the included studies,more high-quality clinical trials were required to confirm its efficacy.
To evaluate the efficacy and safety of Gantaishu Capsules in the treatment of viral B hepatitis. The randomized controlled trials( RCT) retrieved from Cochrane Library,PubMed,Sino Med,CNKI,Wan Fang and VIP were enrolled. The methodology quality of the included studies was evaluated,and a Meta-analysis was performed using Rev Man 5. 3 software. A total of six randomized controlled trials were included. Meta-analysis results showed that the similarities in the negative conversion rate of HBe Ag( RR = 2. 09,95%CI[0. 90,4. 85],P = 0. 09,I2= 0%),the HBV-DNA negative rate( RR = 1. 49,95% CI[0. 56,3. 95],P = 0. 43,I2= 0%) and the changes in ALT levels before and after treatment( RR =-6. 28,95%CI[-72. 83,60. 27],P = 0. 85,I2= 99%),with no statistical difference. In terms of quality of life,Gantaishu Capsules can significantly alleviate the symptoms of hepatitis B patients,with less adverse reactions. Gantaishu Capsules and Dongbao Gantai Tablets were similar in antiviral effect. In this term,Gantaishu Capsules was superior to Dangfei Liganning Capsules. It can significantly alleviate the symptoms of chronic hepatitis B patients,with a good clinical safety.Therefore,it can be applied in the case of syndrome differentiation and treatment. In view of the low quality of the included studies,more high-quality clinical trials were required to confirm its efficacy.
引文
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[15]王玉清,马晓雨,张玉良.晶珠肝泰舒胶囊治疗80例病毒性肝炎疗效分析[J].青海医药杂志,2001(2):54.
[16]顾群.晶珠肝泰舒胶囊治疗慢性肝炎60例疗效观察[J].辽宁中医杂志,2000(9):407.
[17]王武华.晶珠肝泰舒胶囊治疗肝炎肝硬变60例[J].辽宁中医学院学报,2000(2):125.
[18]刘建平,Heather Mc Intosh,林辉.中草药治疗慢性乙型肝炎随机对照试验的系统评价[J].中国循证医学,2001(1):16.
[2]杨丽春.2004—2012年我国法定病毒性肝炎流行病学特征分析[J].内蒙古医学杂志,2013,45(5):572.
[3]杜琼媛,林海春,卢丽萍,等.460例病毒性乙型肝炎疫情的流行病学描述性分析[J].中国自然医学杂志,2009,11(6):440.
[4]许春梅.某市2010年—2014年散发性乙型病毒性肝炎的流行病学特征[J].中国医药指南,2015,13(28):108.
[5]杨昌琨,陈建杰.中医辨证治疗慢性乙型肝炎5年回顾性研究[J].长春中医药大学学报,2011,27(2):241.
[6]孙元培,郭晓霞.基于中医传承辅助平台挖掘姜良铎教授治疗慢性乙型肝炎方药规律[J].中国实验方剂学杂志,2017,23(6):210.
[7]肖小河,赵艳玲,袁海龙,等.21世纪抗肝炎中药研究开发的机遇与挑战[J].中国中药杂志,2001,26(10):14.
[8]沈国辉.晶珠肝泰舒治疗慢性乙型肝炎的疗效观察[C].上海:全国第七届农村基层中西医结合学术暨工作交流会,2002.
[9]闵佳,常德成,陈晓.晶珠肝泰舒治疗慢性乙型肝炎60例疗效观察[J].现代医药卫生,2001(10):788.
[10]张伟,李保森,邢汉前,等.晶珠泰舒治疗慢性乙型肝炎45例疗效观察[J].现代医药卫生,2001(10):789.
[11]中华传染病与寄生虫病分会,肝病分会.病毒性肝炎的诊断标准[J].中西医结合肝病杂志,2001,11(1):56
[12]佘会元.晶珠肝泰舒胶囊治疗慢性乙型肝炎疗效观察[C].贵阳:2002全国中西医结合肝病学术会议,2002.
[13]刘红,杨大国,王东,等.晶珠肝泰舒联合拉米夫定治疗慢性乙型肝炎临床疗效观察[J].中西医结合肝病杂志,2002(2):74.
[14]马晓雨.藏药晶珠肝泰舒治疗慢性乙肝33例疗效观察[J].中国民族医药杂志,2001(3):6.
[15]王玉清,马晓雨,张玉良.晶珠肝泰舒胶囊治疗80例病毒性肝炎疗效分析[J].青海医药杂志,2001(2):54.
[16]顾群.晶珠肝泰舒胶囊治疗慢性肝炎60例疗效观察[J].辽宁中医杂志,2000(9):407.
[17]王武华.晶珠肝泰舒胶囊治疗肝炎肝硬变60例[J].辽宁中医学院学报,2000(2):125.
[18]刘建平,Heather Mc Intosh,林辉.中草药治疗慢性乙型肝炎随机对照试验的系统评价[J].中国循证医学,2001(1):16.